To assess memory function at 4 months after Hippocampus Avoidance-PCI versus standard whole brain PCI
ID
Source
Brief title
Condition
- Other condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Health condition
cognitieve functies
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess memory function at 4 months after PCI versus HA-PCI. A decline of 5
points in the total recall score will be considered as a failure.
Secondary outcome
* To assess early and late neurotoxicity and quality of life following PCI with
or without hippocampal sparing.
* To assess structural brain damage from PCI on MRI with and without sparing of
the hippocampus.
* To assess the incidence and location of brain metastases after PCI with or
without hippocampal sparing.
* Overall survival.
Background summary
The high incidence of brain metastases is a major problem in lung cancer
patients because of serious impairment in patients* quality of life, shortened
survival and life-threatening symptoms. Systemic treatment options to treat
brain metastases are limited. If brain metastases become symptomatic
radiotherapy is often inadequate to diminish the neurological symptoms. PCI
proved to reduce the incidence of brain metastases significantly in patients
with limited and extensive SCLC in remission after treatment of the primary
tumor, and increased the patient*s overall survival. Cognitive deficits after
Prophylactic Cranial Irradiation (PCI) play an important role in the
neurological morbidity after radiotherapy.
The reduction in the incidence of brain metastases after prophylactic whole
brain irradiation should be counterbalanced with the radiotherapy associated
neurological complications. Observed symptoms after PCI include predominantly
mental slowing, loss of concentration, short memory problems and fatigue. It is
described that blocking of the hippocampi (a centrally located structure)
during PCI may diminish cognitive side effects. Modern radiotherapy techniques
makes the relative sparing of this hippocampal area achievable. Recent attempts
to reduce cognitive side effects of PCI by introducing hippocampi avoidance PCI
(HA-PCI) have not been fully investigated yet. Patients with small cell lung
cancer will be randomized between conventional whole brain PCI and HA-PCI.
Cognitive functioning will be evaluated with specific neuropsychological tests
5 times from baseline until 2 years after PCI. Also pre and post PCI Magnetic
Imaging (MRI) scans of the brain will be compared to evaluate brain metastases,
white matter lesions and to measure and compare the hippocampi volumes before
and after treatment.
At three time points blood will be drawn for biomarkers (Placental Growth
Factor and neuro-inflammatory markers) as predictors of the incidence of brain
metastases and neuro-inflammation
Study objective
To assess memory function at 4 months after Hippocampus Avoidance-PCI versus
standard whole brain PCI
Study design
It is a randomised Phase III study in which SLCL patients will receive
Prophylactic Cranial Irradiation with or without Hippocampal avoidance.
Since concurrent use of systemic therapy may influence the risk on memory
function and other neurocognitive functioning and influence quality of live,
concurrent systemic treatment is not allowed until three weeks prior to PCI
Patient will have prophylactic whole brain irradiation in 10 fractions with a
total dose of 25Gy.
Study duration is 4 years but two years for the individual patient.
Intervention
Patient will receive prophylactic brain irradiation in 10 fractions
Study burden and risks
Patient will receive a prophylactic PCI versus a HA-PCI in 10 fractions of
radiotherapy. Neurocognitive functions will be tested a 6 time points. Also MRI
scans of the brain will be processed to measure and compare the hippocampal
volumes. And biomarkers will be drawn to analyse predictors
Plesmanlaan 121
AMSTERDAM 1066 CX
NL
Plesmanlaan 121
AMSTERDAM 1066 CX
NL
Listed location countries
Age
Inclusion criteria
* SCLC patients (stage I-III or stage IV without clinical or radiological evidence of brain metastases) candidate for PCI, i.e. without progressive disease after chemo-radiotherapy in stage I-III or after a remission after chemotherapy in stage IV
* WHO-performance status * 2(see Appendix IV).
* Sufficient proficiency in Dutch language
* Written informed consent must be given according to ICH/GCP, national and local regulations
Exclusion criteria
* Prior radiotherapy to the brain
* clinical evidenceof brain metastases or primary brain tumors
* Evidence of progressive extracranial metastatic disease
* Previous malignancy < 2 years ago except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix
* Any systemic anticancer treatment during PCI or within 3 weeks before start PCI.
* Pregnancy or lactation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41178.031.12 |